Using the Simulated Patient Method to Evaluate the Community Pharmacy Management of Childhood Diarrhoea: A Systematic Review

The simulated patient method has been widely used to assess community pharmacy practice in the management of childhood diarrhoea. In such a process, a community pharmacist is required to explore a patient’s history, choose the right medication and provide drug-related information. The aim of this review was to evaluate the aforementioned practice. A comprehensive literature search was carried out over Sage Journal, PubMed, ScienceDirect and Google Scholar, and the analysis was conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses. Eligible articles were those published from 2011 to 2021 and original studies that used the simulated patient method to examine the pharmaceutical services provided by pharmacists in relation to childhood diarrhoea. The eight studies that satisfied the eligibility criteria were reviewed. These investigations were undertaken in Brazil, Nigeria, Turkey, Ethiopia and Pakistan. Five of the studies focused on history taking with regard to the characteristics of diarrhoea and revealed that the evaluated pharmacists asked about patient histories. In terms of therapy, three studies indicated that the evaluated pharmacists recommended the administration of oral rehydration salts. Pharmacies should improve their history-taking process, provide drug-related information and recommend therapies to increase the knowledge of simulated patients about diarrhoea treatment in children.


Introduction
Diarrhoea can be defined as a condition in which the faeces passed by patients are of a soft or liquid consistency; diarrhoeal stool can be fully composed of water and defaecation happens frequently (usually three or more times) within a day.Diarrhoea causes other changes in bowel movement (1,2).It is one of the leading causes of death all over the world, resulting in 5 million-10 million fatalities per year.The highest prevalence of diarrhoea occurs should acquire complete information so that they correctly offer recommendations for treating diarrhoea in children (12).Many respondents have recommended the administration of antibiotics to treat diarrhoea in children and others suggested therapies such as antimotility medication, probiotics and oral rehydration salts.Several respondents have also suggested the use of drugs that have been removed from their original packaging (13).
A systematic review of studies that used the patient simulation method can be conducted to determine how pharmacists provide drug-related information and therapeutic recommendations for children with diarrhoea.However, no such review has been carried out.To address this deficiency, the present research was conducted to systematically evaluate simulated patient based studies on paediatric diarrhoea, with focus directed specifically to the history taking process, the provision of drug-related information and the therapies recommended by pharmacists.

Search Strategies
Articles published in the last 10 years (2011-2021) were searched over the databases of Sage Journal, PubMed, ScienceDirect and Google Scholar.Given the large scale of these databases, broad, thorough and inclusive terms were used in the search.Specifically, the keywords employed were 'simulated patient' OR 'standardised patient' AND 'community pharmacists' AND 'diarrhoea' AND 'childhood' OR 'children'.Mendeley was used to eliminate duplicate citations, after which the generated articles were organised.

Study Selection
The Preferred Reporting Items for Systematic Reviews and Meta-Analyses were used as guidance in conducting and presenting the systematic review.The inclusion criteria were articles published in English, randomised controlled trials, cross-sectional studies, cohort studies, papers discussing history taking by pharmacy professionals for paediatric diarrhoea patients and articles discussing information given by pharmacy professionals in connection to children with diarrhoea.This theme discusses drugs recommended for paediatric diarrhoea.The exclusion criteria were articles for which the full texts are unavailable, literature reviews, in children aged 12 months old-23 months old, followed by children aged 6 months old-11 months old and 23 months old-45 months old.Diarrhoea is contracted mostly by children aged 6 months old-35 months old because this is the period at which they start playing actively and are exposed to the risk of infection (3,4).
Diarrhoea can be classified into acute and chronic diarrhoea, each requiring different ways of handling and treatment.The improper handling and treatment of the condition can be a serious problem, and not all parents understand first aid for childhood diarrhoea.These observations are supported by a study in Tanzania regarding the knowledge of mothers and caregivers regarding diarrhoea management in 5-year-old children.Many of the respondent mothers or caregivers (71%) believe in the use of traditional medicine, namely, guava leaves and fruit, to treat the condition.With regard to chemical medicine, nearly half of the respondents (48.9%) choose metronidazole as diarrhoeal therapy (5).Many parents selfmedicate children with diarrhoea by buying medicine from pharmacies, but they initiate this process by consulting a pharmacist, as shown in several studies (6,7).Pharmacists therefore play an important role in providing appropriate therapeutic recommendations and drug-related information for paediatric patients with diarrhoea.The administration of therapy is adjusted to a patient's clinical condition.
The patient simulation method can be used to determine the effectiveness of pharmacists in providing drug-related information and therapeutic recommendations for children with diarrhoea (8).This method serves as a solution because pharmacists do not realise that they are being evaluated, thereby enabling the acquisition of genuine results.It is hoped that with this method, evaluators can ascertain how pharmacists actually deliver pharmaceutical services related to the management of diarrhoea in children and select treatments according to scenarios designed by researchers (9).
No study has been carried out on the evaluation of pharmacists' provision of drugrelated information on diarrhoea in children, wherein simulated patients act as parents of afflicted children, with guidance from a scenario prepared by a researcher.The closest works in this respect recruited simulated patients for assessment purposes, but they did not explore all the components of drug information extraction (10,11).Pharmacists

Study Characteristics
The eight studies were undertaken in Brazil (15), Nigeria (11), Turkey (16), Ethiopia (17)(18)(19)(20) and Pakistan (21).All the explorations were conducted in community pharmacies and all were of a cross-sectional design, developed specifically to examine the counselling behaviours of pharmacists and their staff when confronted with diverse scenarios involving the treatment of diarrhoea in children (Table 1).

Methods for Assessing Community Pharmacy Practice
The studies used various research approaches, among which three were intended to measure the quality of counselling provided by pharmacists and pharmacy staff.Specifically, two studies used the patient simulation method and provided simulated patients with a checklist of items related to the counselling provided by pharmacists/pharmacy staff (16,21); another two employed the simulated patient method and conducted in-depth interviews with simulated patients after they visited pharmacies (18,19); and four used a combination of patient simulation and questionnaire administration after simulated patient visits to pharmacies (11,15,17,20).
To determine interactions between simulated patients and pharmacists/ pharmacy staff regarding history taking, the provision of drug-related information and recommended therapies, the researchers used data collection sheets, audio recorders and audiovisual recorders.Five studies used data collection sheets, which were filled in following simulated patient visits to the pharmacies where the investigations were conducted (11,16,17,20).Two studies carried out audio recording during simulated patient visits to pharmacies as consultations regarding the treatment of children's diarrhoea took place (18,19).In one study, the researcher operated an audiovisual recording device (hidden micro camera) while the simulated patient interacted with pharmacists/pharmacy staff (15).The researchers and simulated patients documented the results on data collection sheets (Table 1).

Scenarios
All the simulated patients visited pharmacies guided by researcher-prepared scenarios, which all featured the management of childhood diarrhoea.They visited pharmacies asking for diarrhoea medicine to give to toddlers, handbooks, book chapters and reports.The articles yielded by the search were then grouped and analysed.Two research team members (HRP and SAK) independently screened fulltext papers for inclusion, and LL and AWW examined differences in screening.At each level of the screening process, the reasons driving the rejection and documentation of articles were specified.

Data Extraction and Synthesis
Standard data extraction forms were used to document the authors of the sampled studies, years of publication, countries where the studies were carried out and study designs.The forms also contained brief explanations of the techniques, primary outcome measures and conclusions used and drawn by the researchers.The information was compiled in a narrative format, and the findings of each study were examined in terms of three dimensions: patient history taking by pharmacists, information provision by pharmacy professionals and drug recommendations.

Methodological Quality Assessment
The Checklist for Reporting research using Simulated Patient (CRiSP) methodology was used to assess the methodological quality of the papers.The CRiSP can be used as a reporting guideline for authors using the simulated patient methodology.The checklist consists of 23 questions with five possible responses: 'yes', 'no', 'unclear', 'not applicable' and 'partially complete'; a space for brief remarks is also provided (14).Two researchers independently assessed the quality of a given study.Disagreements among team members (HRP, SAK, LL and AWW) were handled through dialogue.

Results
A total of 177 distinct studies were generated from the search (121 from Google Scholar, 51 from ScienceDirect, four from PubMed and one from Sage Journal).Forty-eight studies had the same title and were therefore excluded.After the evaluation of titles and abstracts, 19 were deemed compliant with the requirements for inclusion.Following a thorough analysis, eight studies were retained for the systematic review (Figure 1). a young mother and caregiver (n = 1), a clinical pharmacist (n = 1) and a non-healthcare worker (n = 1).

Counselling for Simulated Patients
A pharmacist or pharmacy staff should enquire about patient history, explain drug-related information and give therapeutic recommendations at each stage of the counselling process.History taking by pharmacists and pharmacy staff varied across the studies.The pharmacists or pharmacy staff enquired into the characteristics of diarrhoea experienced by children, that is, the frequency of bowel movement (11,(15)(16)(17), the presence of mucus and blood in the stool (11,16,17,20) and the duration of a patient's diarrhoea (15)(16)(17)20).In five studies, the pharmacists/pharmacy staff obtained the medication histories of the simulated patients (15,16,18,19,21), whereas in four studies, such inquiries were restricted to the patients' ages (11,16,17,20).Some pharmacists/ pharmacy staff asked about patient symptoms, such as fever (11,16,17,20) and vomiting (16,20).but only one study involved a simulated patient who asked about the treatment of diarrhoea in infants aged 7 months (16).The simulated patients visited pharmacies, asked to see the pharmacists working in the establishments and then consulted them about treating diarrhoea in children.In cases wherein no pharmacist could meet with a simulated patient, the latter made their treatment concerns known to pharmacy staff.The simulated patients explained the symptoms experienced by their children to the pharmacists/pharmacy staff.Only one simulated patient stated that their child had both fever and diarrhoea (15).All the simulated patients visited pharmacies only once.Concerning awareness of visits made by the simulated patients, six studies did not notify the pharmacists of simulated patient arrivals (covert) (11,(17)(18)(19)(20)(21), whereas two distributed consent forms to the pharmacists before visits by the simulated patients (consented) (15,16) (Table 1).

Article Quality
Article quality, which was evaluated using the CRiSP, varied across the studies.None of the explorations fulfilled all the CRiSP requirements, and only four described the study designs used (15,17,20,22).Two studies did not report the number of simulated patients recruited (17,21) but all of them provided details about the featured scenarios, including patient characteristics; patient prompts, scripts and props; models for the delivery of simulated patient assessment; and ethical approval processes, consent from participants and ways of maintaining confidentiality (Table 3).

Discussion
The use of the simulated patient method in eight studies on medication for diarrhoea in children in the community pharmacy setting was systematically examined in this review.Specifically, it probed into pharmaceutical practices in different countries in terms of history taking, therapeutic recommendation and drug-related information provision by pharmacists.The simulated patient method is a practical and straightforward approach to assessing the counselling practices of pharmacists and pharmacy staff in relation to the treatment of childhood diarrhoea, with simulated patients visiting community pharmacies guided by scenarios designed by researchers.By directly visiting pharmacies, simulated patients can obtain information on counselling in connection to medication history, drug-related information and drug recommendations for paediatric diarrhoea.In community pharmacies, pharmacists provide recommendations for treating minor illnesses because patients first meet with a pharmacist before consulting a doctor.Diarrhoea in children is an example of a mild disease for which more people go to pharmacies for suggestions regarding therapy (23).
Six studies employed the simulated patient method to covertly evaluate pharmacist and staff practice behaviours.The findings revealed that the primary objective underlying the use of the simulated patient approach was assessment, rather than instruction meant to enhance the practical skills of pharmacists and their staff.This result also underlines the issue that despite the use of simulated patients in evaluating pharmacy practice, little research has been paid to performance feedback and training/pharmacy education as a means of moulding pharmacists and their employees (24).The most prevalent data collection technique in the reviewed papers was note-taking or checklist completion, and data from these were documented as quickly as possible following simulated patient sessions.Generally, self-completed questionnaires are the most popular data-gathering tools in research on pharmacy practice.However, because of the fallibility of recall and recollection, difficulties can develop from the interval between observation and data recording (9).Two studies made voice recordings of consultations regarding the treatment of children's diarrhoea during simulated patient visits to pharmacies, and one used an audiovisual recording device (hidden micro camera).Instead of depending only on a simulated patient or researcher, a study used audio recording to reduce selectivity and inferences related to researcher observation and recording, thus improving the understanding of specific occurrences during simulated patient encounters (25).
The overall results indicated that most of the pharmacists and pharmacy staff exercised poor pharmaceutical practices in terms of obtaining patient history, offering medication recommendations and providing drug information to simulated patients who acted as parents of children with diarrhoea.Pharmacists must know the different types of diarrhoea, their symptoms and therapeutic management for children to be able to offer appropriate suggestions.To ensure the accuracy    of therapeutic recommendations, pharmacists should acquire a complete patient history (3), including details such as disease onset, duration, severity, frequency and the presence of other symptoms, such as fever and vomiting and stool consistency and composition (e.g.bloody or watery stool).It is also necessary to enquire about a patient's identity (name, age and weight) and whether they have taken certain drugs and have drug allergies (26).
The findings reflected that in most of the studies, the pharmacists did not obtain a complete patient history.They enquired into the characteristics of diarrhoea experienced by children, namely, the frequency of bowel movement (range = 8%-44.2%),the presence of mucus and blood in the stool (range = 1%-49.6%)and the duration of patient diarrhoea (range = 18%-67.3%).Pharmacists need to determine the duration of diarrhoea in children because there are two types of the disease: acute and chronic diarrhoea.If a patient has diarrhoea for less than 14 days, the condition would be diagnosed as acute diarrhoea.The chronic form lasts for more than 14 days.Acute and chronic diarrhoea require different ways of handling and treatment (27).The results are inversely proportional to research conducted in Germany, where 48.7% of the evaluated pharmacists obtained information on diarrhoea duration (28).A study conducted in Iraq found that 80% of the assessed pharmacists asked about diarrhoea in simulated patients who visited pharmacies (26).
Medication history is one of the essential issues that pharmacists must discuss with patients.Obtaining this information is aimed at ruling out drugs that can cause diarrhoea, avoiding the duplication of therapy and preventing drug interactions (23,29).As indicated by the results, in five studies, the pharmacists acquired information related to patients' medication histories (range = 1%-32.5%).The results are almost similar to research conducted in Germany, wherein as many as 32.7% of the pharmacists derived histories related to patient treatment (28).
Diarrhoea is accompanied by several symptoms, including nausea and fever.Nausea often co-occurs in cases of cholera caused by bacterial toxins, while diarrhoeal fever in children can stem from infection by certain bacteria (30).The results showed that in four studies, the pharmacists determined whether the afflicted children had a fever (range = 2%-41.6%)and whether they experienced nausea and vomiting (range = 5%-19%).Pharmacists should look into the symptoms that accompany diarrhoea to provide both pharmacological and non-pharmacological therapeutic recommendations for alleviating these symptoms (23).
The management of mild to severe diarrhoea in children can involve the administration of oral rehydration salts.These can replace bodily fluids and electrolytes that are wasted during diarrhoea, thus preventing dehydration.In the reviewed studies, children with diarrhoea were also administered zinc therapy.Zinc can epithelialise the intestinal wall, whose morphology and functioning are damaged during diarrhoea (1,31).In three studies, oral rehydration salts were recommended (range = 5%-15%), and in three others, this treatment was combined with zinc therapy (range = 31.82%-58.3%).These findings differ from those derived in a study conducted in Surabaya, Indonesia, where only 2.38% of the pharmacists recommended oral rehydration salts and 2.38% suggested the oral rehydration salt-zinc combination (32).In a study in India, only 2.44% of the pharmacists recommended oral rehydration salts (13).In the Iraqi context, the pharmacists did not recommend antibiotic therapy, whether on its own or in combination, for children's diarrhoea (26).This differs from research conducted in India, where 40.24% of the pharmacists recommended antibiotics as a therapy for paediatric diarrhoea (13).The current review uncovered that in three studies, the pharmacists suggested metronidazole as treatment (range = 18.18%-30%).Some cases of diarrhoea are caused by viruses, but the use of antibiotics will not shorten the duration of diarrhoea in children (3).In three studies, the pharmacists suggested loperamide (range = 4.54%-18%), and three others reported recommendations of anthelmintic therapy (range = 19.5%-22.72%).Loperamide and anthelmintics are not recommended as therapy for children with diarrhoea, with major side effects having been reported for the former (27).
For simulated patients to understand diarrhoea experienced by children, pharmacists should provide drug-related information to them.Pharmacists' provision of such information can increase patient knowledge and compliance with therapy (12,26).The results indicated that the pharmacists and pharmacy staff provided substantial drug-related information regarding their recommendations, namely, dosage (range = 19%-90.3%),drug administration frequency (range = 19%-72.6%),indications (range = 10%-80%) and adverse drug reactions (range = 13.3%-31.82%).Pharmacists can increase patient knowledge about diarrhoea therapy for children and accordingly deliver complete counselling.They can attend seminars or other continuing education programmes to increase their own knowledge (10).
Counselling by pharmacists regarding proper drug storage can prevent drug damage due to incorrect storage.If medicine is not stored in the right place, it can be reached and misused by children.Furthermore, many people keep medication at home without realising that they have expired (33).The review showed that only one study described how to store drugs properly (3.8%).Pharmacists can relay to patients that drugs should be stored in a medicine cabinet (34).
There are several limitations to a systematic literature review.The systematic design of the current work is its strength, but it also has certain shortcomings.This review identified eligible studies, but some may have been missed during the keyword search given the existence of multiple synonyms for 'simulated patient'.Because this review was confined to studies published in English, those published in other languages were overlooked.

Conclusion
The use of the patient simulation method in examining paediatric diarrhoea has increased in the pharmaceutical field over the last decade.There are differences in the manner by which patient history is taken, drug-related information is provided and therapeutic recommendations are provided in various countries.Pharmacies need to improve their services by elevating the quality of the aforementioned tasks in their establishments, which in turn, will increase the knowledge of simulated patients about treating diarrhoea in children.

Table 1 .
Characteristics of individual studies and simulated patients

Table 2 .
Counselling given by pharmacist and pharmacy staff

Table 3 .
Assessment using the criteria in the CRiSP checklist